Irish regulators have given the green light for a new lung cancer drug after a significant delay.
Keytruda, which has already been approved in 13 other European countries, will be available to Irish patients from next month after being approved for reimbursement by the Health Service Executive.
The approval of the drug comes just weeks after its manufacturer, MSD, announced plans to invest in a new biotech facility at its previously decommissioned Swords plant.
When completed in 2021, the Swords plant will be dedicated to manufacturing Keytruda, providing 350 jobs.
MSD said the approval was “positive news for patients”. Asked about the impact for the company of the decision, the managing director for MSD Human Health in Ireland, Ger Brennan, said: “The decision to reimburse this drug provides patients with access to drugs that change the way cancer is treated in Ireland.”
Immunotherapy drug
The immunotherapy drug is now MSD’s second best-selling drug with quarterly sales in excess of $1 billion. It is already approved in Ireland for the treatment of malignant melanoma.
This new approval will allow patients with certain advanced lung cancers that have “metastasised” or spread to other parts of the body access to the new generation drug.
Lung cancer is currently the fourth most common cancer in Ireland but the leading cause of death from cancer. About 2,300 people a year are diagnosed with the cancer. Of those, about a quarter have the particular type of cancer that would make them suitable for treatment with Keytruda under the permission now granted.
However, they will first have to undergo a test to show that they have a greater than 50 per cent level of a protein, PD-L1, in the tumour. PD-L1 effectively hides cancer cells from the body’s defence mechanism.
Payment issues
Keytruda works by stopping this protein from hiding the cancer cells. And, while welcoming the sanction for the treatment last night, cancer specialists said it was nearly impossible to get the test carried out at the moment, and questions remain over who will pay for it.
“Approving a drug for patients who cannot avail of it is not approval,” consultant oncologist John Crown said last night.
Prof Crown said the experience of Keytruda, which has been awaiting approval as a cancer therapy for over a year, illustrates an ongoing issue with figuring out how to pay for immune system drugs.
He said that, while not suitable for all cancer patients, Keytruda and similar immunotherapy drugs have wider potential, “offering real hope to people facing fatal diagnosis”.
